Overview

The marketing authorisation for Clopidogrel Ratiopharm GmbH has been withdrawn at the request of the marketing-authorisation holder.

Clopidogrel ratiopharm GmbH : EPAR - Summary for the public

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Product information

Clopidogrel ratiopharm GmbH : EPAR - Product Information

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Suomi (FI) (886.54 KB - PDF)
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Latest procedure affecting product information: IAIN/0036

22/08/2019

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This medicine’s product information is available in all official EU languages.
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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations

български (BG) (1.2 MB - PDF)
español (ES) (1.12 MB - PDF)
čeština (CS) (1.19 MB - PDF)
dansk (DA) (1.12 MB - PDF)
Deutsch (DE) (1.12 MB - PDF)
eesti keel (ET) (1.12 MB - PDF)
ελληνικά (EL) (1.2 MB - PDF)
français (FR) (1.12 MB - PDF)
italiano (IT) (1.12 MB - PDF)
latviešu valoda (LV) (1.2 MB - PDF)
lietuvių kalba (LT) (1.18 MB - PDF)
magyar (HU) (1.2 MB - PDF)
Malti (MT) (1.19 MB - PDF)
Nederlands (NL) (1.12 MB - PDF)
polski (PL) (1.16 MB - PDF)
português (PT) (1.12 MB - PDF)
română (RO) (1.18 MB - PDF)
slovenčina (SK) (1.16 MB - PDF)
slovenščina (SL) (1.13 MB - PDF)
Suomi (FI) (1.12 MB - PDF)
svenska (SV) (1.12 MB - PDF)

Product details

Name of medicine
Clopidogrel ratiopharm GmbH
Active substance
clopidogrel
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Stroke
Anatomical therapeutic chemical (ATC) code
B01AC04

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

  • patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;
  • patients suffering from acute coronary syndrome:
    • non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q wave-myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA);
    • ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

Authorisation details

EMA product number
EMEA/H/C/001165

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Archie Samiel s.r.o.

Slunná 16
61700 Brno
Czech Republic

Marketing authorisation issued
28/07/2009
Revision
12

Assessment history

Clopidogrel ratiopharm GmbH : EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel ratiopharm GmbH-H-C-1165-A20-09 : EPAR - Assessment Report - Article 20

Clopidogrel ratiopharm GmbH : EPAR - Public assessment report

Summary of positive opinion for Clopidogrel Ratiopharm GmbH

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